Cadila Pharma Dholka facility successfully passes USFDA audit
The Dholka manufacturing facility passed the USFDA audit with nil 483 observations
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Browsing Tag
USFDA
Dr Reddy’s Lab launches Treprostinil Injection in the U.S.
Will be supplied as 20 mg/20 mL, 50 mg/20 mL, 100 mg/20 mL or 200 mg/20 mL vials
Zydus gets USFDA approval for Roflumilast Tablets, 250 mcg
Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)
Generic drug development: The way forward
Anantha Keerthi, Partner, Vector Consulting Group, points out that pharma companies need to either launch many new speciality…
Zydus gets USFDA approval for Carbidopa and Levodopa Tablets USP, 10 mg/100 mg, 25 mg/100 mg, and 25…
Carbidopa and Levodopa are used to treat symptoms of Parkinson's disease or Parkinson-like symptoms
Zydus gets USFDA nod for Acetazolamide Tablets USP, 125 mg and 250 mg
Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision.…
Global Pharma recalls 50,000 eye ointment tubes in US
FDA analysis found unopened tubes to be contaminated with bacteria
Alembic Pharma gets USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.15%
Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated…
Glenmark gets ANDA approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%
With this approval, Glenmark is eligible for 180-days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate…
Zydus gets Orphan Drug Designation from USFDA for ZYIL1 to treat Cryopyrin Associated Periodic…
Orphan drug designation by USFDA for ZYIL1 provides eligibility for certain development incentives, including tax credits for…